Recalls / Class III
Class IIID-498-2013
Product
Lisinopril Tablets, USP, 30 mg, Rx only, 100 tablets, NDC 65862-041-01 Manufactured for: Aurobindo Pharma USA Inc. 2400 Route 130 North, Dayton, NJ 08810 Manufactured by: Aurobindo Pharma Limited Hyderabad- 500 072 India
- Brand name
- Lisinopril
- Generic name
- Lisinopril
- Active ingredient
- Lisinopril
- Route
- Oral
- NDCs
- 65862-037, 65862-038, 65862-039, 65862-040, 65862-041, 65862-042
- FDA application
- ANDA077622
- Affected lot / code info
- Lot KP3012001-A Exp.12/13 Lot KP3012002-A Exp.12/13
Why it was recalled
Labeling: Label Error on Declared Strength: Incorrect strength on side display panel of label
Recalling firm
- Firm
- Aurobindo Pharma USA Inc
- Manufacturer
- Aurobindo Pharma Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 666 Plainsboro Rd. Suite 210, N/A, Plainsboro, New Jersey 08536-3004
Distribution
- Quantity
- 1776 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2013-04-09
- FDA classified
- 2013-05-30
- Posted by FDA
- 2013-06-05
- Terminated
- 2014-01-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-498-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.